Class 1 medical device

Class 1 Medical Device

As per European Medical Device Regulation (MDR) Class 1 medical devices present minimal potential for harm to the user and are often simpler in design than Class 1s, Class 1m, Class IIa, Class IIb or Class III Medical Devices.

Most Class 1 medical device can be self Certified by EU MDR or even as per US FDA regulations.

Class 1 Medical Device, CE marking, Notified Body involvement is not mandatory. Class 1 products manufactures ISO 13485 implementation and certification is not required.

Minimum level of GMP compliance is recommended. In short, some controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device is required.

Class 1 Medical Device are again divided into two:

All Class 1 Medical Device can affix CE Mark by self-declaration. The manufacturer is responsible for ensuring that his product complies with all the relevant Essential Requirements of the Directive and must complete the Essential requirement Check-list.

We support class 1 Medical Device manufactures with the following Services

(a) Guidance & Technical File

(b) Arrange Certificate of Compliance from and European Third Party.

(C) Arrange EU Representative from Europe

(d) Arrange Free Sale Certificate from Europe.

More details about CE Certification Process click here .

Steps before Class 1 Medical Device Self Decleration

All class 1 medical devices must go through few steps before placing it on European market. They are the following..

  • Step 1: Research and competitor analysis and make sure the product is a medical device.
  • Step 2: Confirm that the Medical Device falls under self declaration ie; class 1.
  • Step 3: Ensure that the general safety and performance requirements have been met.
  • Step 4: Clinical Evaluation performed and Report is available as per MDR and MEDDEV 2.7/1 Rev. 4
  • Step 5: Availablity of Primary & Secondary Labels and packing plans
  • Step 6: EAR Agreement for Non European manufactures.
  • Step 7: Assure the latest revision of Technical documentation is availabel with declaration of Conformity.

Third Party CE Compliance Certificate for Class I medical Devices

Class I non sterile, non measuring medical devices do not need apply with Notified Body can be certified by a third party certification body. Manufactures must understand the fact, Third party Certificate is not mandatory for class I device instead a self attested declaration of conformity is good enough.

We can organize Third Party CE Compliance Certificate from our German office

Client Testimonial

Class 1 Medical Device Reviewed by Mrs. Isabella Mia on . Technical File with DOC and Third Party Compliance Certificate in 15 days!! Class I medical device. Thanks for support in Medical Device Class 1 Process. Rating: 4.9

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